Ridge Preservation Following Tooth Extraction

Not Applicable

Withdrawn

• Conditions: Tooth Extraction; Alveolar Bone Resorption
• Interventions: Other: Reducing dimensional changes following tooth extraction

• Registration Number: NCT05485194
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.

Detailed Description

The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Study Start: 2025-12-01
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age ≥18 years
• a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
• a tooth requiring extraction

Exclusion Criteria

• thyroid dysfunctions
• diabetes mellitus
• history of a chronic use of corticosteroids (>6 months)
• history of oral/intravenous bisphosphonates within the past 2 years
• smoking
• history of other systemic conditions that could affect bone integrity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Alveolar ridge preservation (ARP)	Reducing dimensional changes following tooth extraction	The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture.
Titanium bone screw (TBS)	Reducing dimensional changes following tooth extraction	One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction.

Primary Outcome Measures

Name	Time	Method
The width of the alveolar bone	up to 6 months	Dimensional changes in the width of the alveolar bone following tooth extraction